Nivolumab or Expectant Observation Following Ipilimumab, Nivolumab, and Surgery in Treating Patients With High Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03220009
Phase
PHASE2
Status
Withdrawn

Conditions

  • Cervical Carcinoma
  • Esophageal Carcinoma
  • Mucosal Melanoma
  • Mucosal Melanoma of the Head and Neck
  • Oral Cavity Mucosal Melanoma
  • Recurrent Melanoma
  • Stage II Vulvar Cancer AJCC v7
  • Stage III Vulvar Cancer AJCC v7
  • Stage IIIA Vulvar Cancer AJCC v7
  • Stage IIIB Vulvar Cancer AJCC v7
  • Stage IIIC Vulvar Cancer AJCC v7
  • Stage IV Oral Cavity Cancer AJCC v6 and v7
  • Stage IV Vulvar Cancer AJCC v7
  • Stage IVA Oral Cavity Cancer AJCC v6 and v7
  • Stage IVB Oral Cavity Cancer AJCC v6 and v7
  • Stage IVC Oral Cavity Cancer AJCC v6 and v7
  • Vaginal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Conventional Surgery — PROCEDURE
    Undergo surgery
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV
  • Patient Observation — OTHER
    Undergo active surveillance
  • Radiation Therapy — RADIATION
    Undergo RT

Study Details

This randomized phase II trial studies how well nivolumab or expectant observation following ipilimumab, nivolumab, and surgery work in treating patients with high-risk mucosal melanoma that is restricted to the site of origin without evidence of spread, has spread to a local and regional area of the body, or has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Sometimes the mucosal melanoma may not need more treatment until it progresses. In this case, observation may be sufficient. It is not known if nivolumab or expectant observation following ipilimumab, nivolumab, and surgery may be better in treating patients with mucosal melanoma.

Key Dates

Start date
Nov 3, 2017
Status verified
Oct 2018
Primary completion
Jul 1, 2021
Completion
Jul 1, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I (nivolumab, ipilimumab, surgery, active surveillance)
    PART I: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Within 3-6 weeks after receiving nivolumab and ipilimumab, patients undergo surgery per standard of care. Within 84 days of last surgical resection, patients may also undergo adjuvant RT, if clinically appropriate. PART II: Patients undergo active surveillance for 1 year.
  • Experimental: Arm II (nivolumab, ipilimumab, surgery, nivolumab)
    PART I: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Within 3-6 weeks after receiving nivolumab and ipilimumab, patients undergo surgery per standard of care. Within 84 days of last surgical resection, patients may also undergo adjuvant RT, if clinically appropriate. PART II: Patients receive nivolumab IV over 30 minutes once every 2 weeks for 4 doses. Patients then continue to receive nivolumab IV over 30 minutes once every 4 weeks for up to 11 doses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Recurrence free survival (RFS) [ Time Frame: From randomization to either adjuvant nivolumab or observation until evidence of disease recurrence, assessed up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Alliance for Clinical Trials in OncologyBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
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By research site
Alliance for Clinical Trials in Oncology· Boston, MA

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